U.S. patent number 10,201,631 [Application Number 15/661,972] was granted by the patent office on 2019-02-12 for wound management system and methods of using.
This patent grant is currently assigned to Medline Industries, Inc.. The grantee listed for this patent is Medline Industries, Inc.. Invention is credited to Debashish Chakravarthy, Bridget Donovan, Angie Duncan, Maria Miller.
United States Patent |
10,201,631 |
Duncan , et al. |
February 12, 2019 |
Wound management system and methods of using
Abstract
A wound management system can comprise a surgically acceptable
adhesive disposed over a wound and a surgically acceptable film
repositionably disposed over the surgically acceptable adhesive,
and methods of managing a wound involving the same.
Inventors: |
Duncan; Angie (Mundelein,
IL), Donovan; Bridget (Mundelein, IL), Chakravarthy;
Debashish (Mundelein, IL), Miller; Maria (Mundelein,
IL) |
Applicant: |
Name |
City |
State |
Country |
Type |
Medline Industries, Inc. |
Mundelein |
IL |
US |
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Assignee: |
Medline Industries, Inc.
(Mundelein, IL)
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Family
ID: |
54141075 |
Appl.
No.: |
15/661,972 |
Filed: |
July 27, 2017 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20180161475 A1 |
Jun 14, 2018 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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14664264 |
Mar 20, 2015 |
9750838 |
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61968796 |
Mar 21, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61L
15/58 (20130101); A61L 26/0061 (20130101); A61L
26/0066 (20130101); A61L 15/42 (20130101); A61L
15/44 (20130101); A61L 15/58 (20130101); C08L
35/04 (20130101); A61L 2300/428 (20130101); A61L
2300/22 (20130101); A61L 2300/406 (20130101); A61L
2300/404 (20130101) |
Current International
Class: |
A61L
15/42 (20060101); A61L 26/00 (20060101); A61L
15/58 (20060101); A61L 15/44 (20060101); C08L
35/04 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0353972 |
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Jan 1994 |
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EP |
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WO 2006/127385 |
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Nov 2006 |
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WO |
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WO 2013/076450 |
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May 2013 |
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WO |
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WO 2015/143341 |
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Sep 2015 |
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WO |
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Other References
Supplementary European Search Report for European Application No.
15764414.7, dated Oct. 2, 2017, 6 pages. cited by applicant .
International Search Report and Written Opinion for International
Application No. PCT/US2015/021782, dated Jun. 18, 2015, 11 pages.
cited by applicant.
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Primary Examiner: Sasan; Aradhana
Attorney, Agent or Firm: Cooley LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a Continuation of U.S. patent application Ser.
No. 14/664,264, filed Mar. 20, 2015, which claims the priority
benefit to U.S. Provisional Application No. 61/968,796, filed Mar.
21, 2014, the disclosure of which is incorporated by reference
herein in its entirety.
Claims
We claim:
1. A wound management system, comprising a surgically acceptable
skin adhesive disposed over and in direct contact with a wound; and
a surgically acceptable film repositionably disposed over the
surgically acceptable skin adhesive, wherein both the surgically
acceptable skin adhesive and the surgically acceptable film cover
the wound.
2. The wound management system of claim 1, wherein the surgically
acceptable skin adhesive is a cyanoacrylate adhesive.
3. The wound management system of claim 2, wherein the surgically
acceptable skin adhesive comprises at least one of
butylcyanoacrylate and octylcyanoacrylate.
4. The wound management system of claim 3, wherein the surgically
acceptable adhesive comprises octylcyanoacrylate.
5. The wound management system of claim 1, wherein the surgically
acceptable film is in contact with the surgically acceptable skin
adhesive.
6. The wound management system of claim 5, wherein the surgically
acceptable film comprises a first side and a second side, the first
side having a pressure sensitive adhesive disposed thereon.
7. The wound management system of claim 1, wherein the surgically
acceptable film comprises a silicone sheet.
8. The wound management system of claim 1, wherein the surgically
acceptable film comprises a silicone adhesive.
9. The wound management system of claim 1, wherein the surgically
acceptable film is formed by disposing a curable gel or curable
liquid over the surgically acceptable skin adhesive and curing the
curable gel or curable liquid into a film.
10. The wound management system of claim 1, wherein the surgically
acceptable film is permeable to at least one of air, moisture,
blood, and wound exudate.
11. The wound management system of claim 1, wherein the surgically
acceptable film is semi-permeable to at least one of air, moisture,
blood, and wound exudate.
12. The wound management system of claim 1, wherein the surgically
acceptable film is impermeable to at least one of air, moisture,
blood, and wound exudate.
13. The wound management system of claim 1, wherein the surgically
acceptable film is transparent or translucent.
14. The wound management system of claim 1, wherein the surgically
acceptable film is opaque.
15. The wound management system of claim 1, wherein the surgically
acceptable film is adapted to change from transparent or
translucent to opaque.
16. The wound management system of claim 1, wherein the surgically
acceptable film is in the form of a surgically acceptable tape,
dressing or bandage.
17. The wound management system of claim 1, wherein the surgically
acceptable adhesive is an atraumatic adhesive.
18. The wound management system of claim 1, wherein the surgically
acceptable film comprises one or more of silicone, paper,
cellulose, microporous material, polyamide, and polyacrylate,
polyester, copolyester, and fabric.
19. The wound management system of claim 18, wherein the surgically
acceptable film comprises silicone.
20. The wound management system of claim 19, wherein the surgically
acceptable film has a first surface comprising silicone and a
second surface comprising one or more of paper, cellulose,
microporous material, polyamide, and polyacrylate, polyester,
copolyester, and fabric.
21. The wound management system of claim 1, wherein the surgically
acceptable film is perforated.
22. The wound management system of claim 1, wherein the surgically
acceptable film is not perforated.
23. The wound management system of claim 1, further comprising an
absorbent dressing disposed over the surgically acceptable
film.
24. The wound management system of claim 1, further comprising at
least one topically administrable active agent.
25. The wound management system of claim 24, wherein the topically
administrable active agent comprises one or more of antimicrobials,
moisturizers, vitamins, skin nutrients, beneficial oils, and scar
reducing agents.
26. The wound management system of claim 1, wherein the surgically
acceptable film comprises one or more markings delineating one or
more pre-determined shapes on the film.
27. The wound management system of claim 3, wherein the surgically
acceptable skin adhesive has an amount from about 0.1 mL to about
10 mL.
Description
BACKGROUND
Wound management systems are used to assist in closing and covering
wounds, lacerations, and incisions, for example those caused by
surgery. Conventional wound dressings and bandages can be effective
in covering and protecting wounds, may not be effective in sealing
and aligning the tissue of the wound or incision. Topical skin
adhesives (e.g., cyanoacrylates) have been employed to seal and
align tissue edges in incisions, but may not be sufficient or
effective in covering and protecting the incision. Wound management
systems have been proposed where a conventional skin adhesive
composition is "reinforced" by applying it over conventional wound
dressing materials, such as adhesive tape (e.g., as described in US
2009/0036921), whereby the skin adhesive penetrates the structure
of the tape. The resulting "composite" structure reinforces the
skin adhesive and may provide a barrier to moisture and
contamination. However, such "composite" systems are relatively
rigid and tend to be uncomfortable for the patient while the system
is in place, and may cause additional trauma or discomfort when it
is removed. Further, because such composite wound management
systems adhere strongly to the skin, it is not possible to
reposition such composites during application, or as needed during
the wound healing process. Thus, if a "composite" wound management
system is misaligned during application, or becomes misaligned
during use, it may be necessary for it to be removed entirely and
reapplied, thereby causing additional trauma to the wound. Thus,
there is a need for a wound management system that addresses these
and other problems.
SUMMARY OF THE INVENTION
A wound management system can comprise a surgically acceptable skin
adhesive disposed over a wound and a surgically acceptable film
repositionably disposed over the surgically acceptable skin
adhesive. The surgically acceptable adhesive can comprise a
cyanoacrylate adhesive, such as at least one of butylcyanoacrylate
and octylcyanoacrylate, and particularly octylcyanoacrylate.
The surgically acceptable film can be in contact with the
surgically acceptable skin adhesive, and can comprise a first side
and a second side, the first side having a pressure sensitive
adhesive disposed thereon.
The surgically acceptable film can comprise a silicone sheet. In
some embodiments, the surgically acceptable film can comprise a
silicone adhesive. In other embodiments, the surgically acceptable
adhesive can be an atraumatic adhesive.
In some embodiments, the surgically acceptable film can be formed
by disposing a curable gel or curable liquid over the surgically
acceptable adhesive and curing the curable gel or curable liquid
into a surgically acceptable film. In other embodiments, the
surgically acceptable film can be permeable to at least one of air,
moisture, blood, and wound exudates. In still other embodiments,
the surgically acceptable film can be impermeable to at least one
of air, moisture, blood, and wound exudates. In yet other
embodiments, the surgically acceptable film can be semi-permeable
to at least one of air, moisture, blood, and wound exudates.
In particular embodiments, the surgically acceptable film can be
transparent or translucent. In other particular embodiments, the
surgically acceptable film can be opaque. In yet other embodiments,
the surgically acceptable film can be adapted to change from
transparent or translucent to opaque.
In some embodiments, the surgically acceptable film can comprise
one or more of silicone, paper, cellulose, microporous material,
polyamide, polyacrylate, polyester, copolyester, and fabric. In
particular embodiments, the surgically acceptable film comprises
silicone. For example the surgically acceptable film can have a
first surface comprising silicone and a second surface comprising
other suitable materials. In still other embodiments, the
surgically acceptable film is composed primarily of silicone.
In some embodiments, the surgically acceptable film is perforated,
and in other embodiments it is not perforated. In other
embodiments, the surgically acceptable film is formed in a
pre-determined shape, for example a shape that is suitable for
disposition over particular anatomical features, or suitable for
disposition over particular types of wounds or incisions. In still
other embodiments, the surgically acceptable film is marked with
one or more markings delineating one or more pre-determined shapes
for the film, whereby a physician can more readily trim the film to
a desired shape.
In particular embodiments, the wound management system can further
comprise an absorbent dressing disposed over the surgically
acceptable film. In other particular embodiments, the wound
management system can further comprise at least one topically
administrable active agent, for example, one or more of
antibiotics, anti-virals, antimicrobials, moisturizers, vitamins,
skin nutrients, beneficial oils, and scar reducing agents. In still
other embodiments, the wound management system can further comprise
both absorbent dressing disposed over the surgically acceptable
film, and at least one of the topically administrable active agents
described herein.
A method of managing a wound can comprise applying a surgically
acceptable skin adhesive to a wound and applying a repositionable
surgically acceptable film over the surgically acceptable skin
adhesive. In some embodiments, the method can further comprise
curing the surgically acceptable skin adhesive, wherein the cured
skin adhesive does not impede the repositionability of the
surgically acceptable film. In other embodiments of the method, the
surgically acceptable skin adhesive can comprise one or more of
butylcyanoacrylate and octylcyanoacrylate, and in particular can
comprise octylcyanoacrylate.
In particular embodiments, the method can comprise contacting the
repositionable surgically acceptable film with the surgically
acceptable skin adhesive. In other particular embodiments, the
repositionable surgically acceptable film is applied before the
surgically acceptable skin adhesive is completely cured. In yet
other particular embodiments, the repositionable surgically
acceptable film is applied after the surgically acceptable skin
adhesive is completely cured.
In some cases, the repositionable surgically acceptable film is a
surgically acceptable tape, dressing, or bandage. In particular
cases, the repositionable surgically acceptable film is applied as
a transparent or translucent film, and becomes opaque over time. In
other cases, the method further comprises applying an absorbent
dressing over the repositionable surgically acceptable film. In
some embodiments, the method further comprises applying a topically
acceptable active agent, for example, one or more of antibiotics,
anti-virals, anti-microbials, moisturizers, vitamins, skin
nutrients, beneficial oils, and scar reducing agents, over the
wound.
In some embodiments, the surgically acceptable skin adhesive is
applied from a sponge-tipped applicator, a high-density foam
applicator, a flocked-tipped applicator, or a silicone-tipped
applicator. In particular embodiments, the applicator is a
blister-sealed applicator.
The method can further comprise repositioning the repositionable
surgically acceptable film after applying the repositionable
surgically acceptable film.
DETAILED DESCRIPTION
It should be understood that all publications, journal articles,
patents, and the like that are mentioned in this specification are
hereby incorporated by reference in their entirety and for all
purposes.
Unless otherwise defined, all terms used in this specification are
intended to have the meaning that a person of ordinary skill in the
art would have ascribed to them at the time of the invention.
Certain terms have particular meanings, as follows.
"Repositionable" and conjugations thereof refers to a relationship
whereby a plurality elements are connected in such a way that at
least one element can be moved in space with respect to at least
one other element. With respect to the repositionable surgically
acceptable film, the term "repositionable" refers to the ability to
remove the surgically acceptable film, either partially or
completely from the wound site and replace it in a different
position or orientation without appreciably removing or damaging
the surgically acceptable skin adhesive, or causing more than a de
minimus amount of additional trauma to the wound site. In some
embodiments, "repositionable" can refer to the ability of e.g. a
physician to completely remove the surgically acceptable film from
the wound site, without appreciably removing or damaging the
surgically acceptable skin adhesive, or causing more than de minims
amount of additional trauma to wound site, and completely replacing
the originally applied surgically acceptable film with another
repositionable surgically acceptable film.
"Opaque" refers to substances that have at least 70% opacity. The
percent opacity for plastic or polymeric materials can be
determined by the ASTM D1746 Standard Test Method for Transparency
of Plastic Sheeting, and the opacity of paper materials can be
determined by the ASTM D589-97(2007) Standard Test Method for
Opacity of Paper.
A material is considered "permeable" if the moisture vapor
transmission is at least 301 g/m.sup.2, for example about 301-800
g/m.sup.2 when tested according to the ASTM E96 Standard Test
Method for Water Vapor Transmission of Materials.
A material is considered "semi-permeable" if the moisture vapor
transmission is about 101-300 g/m.sup.2 when tested according to
the ASTM E96 Standard Test Method for Water Vapor Transmission of
Materials.
A material is considered "impermeable" if the moisture vapor
transmission is less than about 100 g/m.sup.2 when tested according
to the ASTM E96 Standard Test Method for Water Vapor Transmission
of Materials.
"Butylcyanoacrylate" is sometimes known in the art as "butyl
cyanoacrylate" and can include any of n-butylcyanoacrylate,
iso-butylcyanoacrylate, sec-butylcyanoacrylate, and
tert-butylcyanoacrylate, either alone or in any combination, and
particularly n-butylcyanoacrylate.
"Octylcyanoacrylate" is sometimes known in the art as "octyl
cyanoacrylate" and can include any isomer thereof alone or multiple
isomers in any combination, and particularly straight-chained
octylcyanoacrylate.
One of skill in the art understands that other cyanoacrylates can
be substituted for butyl cyanoacrylate or octylcyanoacrylate
provided that such other cyanoacrylates provide acceptable skin
adhesive properties similar to those of butylcyanoacrylate or
octylcyanoacrylate.
The wound management systems of the present invention can comprise
a surgically acceptable skin adhesive disposed over a wound and a
surgically acceptable film repositionably disposed over the
surgically acceptable skin adhesive, Repositionable films can be in
any form such as gauzes, bandages, tape, sheets, and the like, so
long as the film can be repositioned after its initial application.
The repositionable disposition of the film can have a variety of
advantages over films that are not repositionable. For example,
because a repositionably disposed film is not strongly adhered to
the skin adhesive, the resulting wound management system is more
flexible (less rigid) than a wound management system in which the
film and skin adhesive form an integrated composite (e.g., systems
in which the adhesive penetrates the film, thereby incorporating
the film within the adhesive). This increased flexibility
substantially increases patient comfort and reduces trauma upon
removal of the wound management system after wound healing is
complete. Also, because the surgically acceptable film component of
wound management systems of the present invention are
repositionable, if the film is not initially applied in the ideal
location, as can happen in emergency or high stress situations,
then the film can be repositioned to a more ideal location at a
later time. Similarly, if the ideal position of a repositionable
film changes during the course of wound healing, for example,
because of changes in the wound, it can be repositioned as
needed.
The surgically acceptable skin adhesive can comprise any suitable
skin adhesive, particularly a cyanoacrylate adhesive. Any
cyanoacrylate suitable for use as a skin adhesive can be used. In
particular, the cyanoacrylate skin adhesive can comprise at least
one of butylcyanoacrylate and octylcyanoacrylate, and more
particularly can comprise octylcyanoacrylate. The surgically
acceptable skin adhesive, such as any of the surgically acceptable
skin adhesives described herein, can be an atraumatic adhesive, for
example, a silicone adhesive. Examples of suitable surgically
acceptable skin adhesives include SurgiSeal.RTM. and Skinaffix.RTM.
(both available from Medline).
The surgically acceptable film can be disposed over the surgically
acceptable skin adhesive. Thus, the surgically acceptable film can
contact the surgically acceptable skin adhesive, although this is
not required unless otherwise specified.
The surgically acceptable film can be any film that can be used in
surgery, and can have any surgically acceptable shape, size, or
content, depending on the intended use, size and type of wound to
be managed, and other factors understood in the art.
The surgically acceptable film can comprise one or more of
silicone, paper, cellulose, microporous material, polyamide,
polyurethane, polyacrylate, polyester, copolyester, and fabric. In
particular, the surgically acceptable films can comprise silicone,
although no particular components are required unless otherwise
specified. Examples of suitable surgically acceptable films include
Gentac.RTM. (available from Medline).
The surgically acceptable film can be in any suitable form. For
example, the surgically acceptable film can be in the form of a
sheet, dressing, or tape, although this is not required unless
otherwise specified. In particular, the surgically acceptable film
can be in the form of a silicone sheet. Depending on the intended
use, the surgically acceptable film can be either perforated or not
perforated.
The surgically acceptable film can further comprise a film
adhesive, such as a silicone adhesive or a pressure sensitive
adhesive. When the surgically acceptable film has a first side and
a second side, a pressure sensitive film adhesive can be disposed
on the first side. The film adhesive can be an atraumatic adhesive.
The atraumatic film adhesive can be one that does not strongly
adhere to the surgically acceptable skin adhesive or to the
patient's skin, but instead allows the surgically acceptable film
to be repositioned. Such film adhesives can be low-tack, reusable,
pressure sensitive adhesives, for example, sphere shaped acrylic
adhesives such as those used in conjunction with repositionable
articles such as POST-IT.RTM. notes. In addition, many silicone
adhesives are repositionable.
The surgically acceptable film can be formed before being disposed
on the surgically acceptable adhesive (e.g., provided as a
pre-formed sheet or tape), or can be formed in situ over the
surgically acceptable skin adhesive. In the latter case, the
surgically acceptable film can be formed by disposing a curable gel
or curable liquid over the surgically acceptable skin adhesive and
curing the curable gel or curable liquid into a surgically
acceptable film.
The surgically acceptable film can be permeable to at least one of
air, moisture, blood, and wound exudates, Such film can be useful
in situations where it is beneficial to allow passage of at least
one of air, moisture, blood, and wound exudates through the film.
For example, when wound healing would be benefitted by allowing
wound exudates, such as puss, to drain from the wound site, a
permeable film can be desirable. Permeable films can include, for
example, permeable gauze or paper, although some gauze and paper
can be semi-permeable or impermeable.
The surgically acceptable film can be semi-permeable to at least
one of air, moisture, blood, and wound exudates. Such films can be
useful in situations where it is beneficial to allow limited
passage of at least one of air, moisture, blood, and wound exudate
through the film. Semi-permeable films can include, for example,
semi-permeable polyamides or polyurethanes, although some polyamide
and polyurethane films can be permeable or impermeable.
The surgically acceptable film can be impermeable to at least one
of air, moisture, blood, and wound exudates. Such films can be
useful in situations where it is beneficial to minimize or prevent
the passage of at least one of air, moisture, blood, and wound
exudates through the film. For example, when a wound at risk for
infection, an impermeable film may reduce the risk of infection.
Impermeable films can include, for example, silicone or
polyurethane, although some silicone and polyurethane films can be
permeable or semi-permeable.
The surgically acceptable film can be transparent or translucent.
In such cases, it can be possible to observe the wound through the
surgically acceptable film without removing the surgically
acceptable film. Transparent and translucent films can be made out
of any transparent or translucent material, such as transparent or
translucent silicone, polyurethane, and the like.
The surgically acceptable film can be opaque, in which case the
wound can be concealed, for example, for cosmetic purposes. Opaque
films can be made by adding a surgically acceptable dye to an
otherwise transparent or translucent material, or by using a
material that is opaque (e.g., opacifying agents such as inorganic
fillers such as titanium dioxide) without the addition of a
dye.
The surgically acceptable film can be transparent or translucent
when first applied, and then become opaque over time. The color
change can occur, for example, by oxidation of the surgically
acceptable film or by reaction of one or more components of the
surgically acceptable film with wound exudate.
The surgically acceptable film can be provided in a pre-determined
shape, such as a rectangle, square, circle, and the like, or
irregularly configured to better conform to the contours of a
patient's anatomy. In addition or in the alternative, the
surgically acceptable film can be provided with one or more
markings delineating one or more pre-determined shapes on the film.
The one or more markings can be a guide, allowing the user to
easily cut the surgically acceptable film into one or more of the
pre-determined shapes, depending on the intended use, the size of
the wound, the type of the wound, etc. The surgically acceptable
film can also be provided partially (e.g., "Kiss Cut") or
completely precut, optionally on a release film or liner.
The wound management system can further comprise an absorbent
dressing disposed over the surgically acceptable film. The
absorbent dressing can be any absorbent dressing known in the art,
and can comprise, for example, one or more of textiles, wovens,
non-wovens, fabrics, bandages, gauze, and the like.
The wound management system can further comprise at least one
active agent, for example to aid in wound healing. Exemplary active
agents include one or more of antibiotics, anti-virals,
antimicrobials, moisturizers, vitamins, skin nutrients, beneficial
oils, and scar reducing agents. The active agent can be
incorporated into one or more of the surgically acceptable skin
adhesive, the surgically acceptable film, or a separate active
agent containing layer.
In use, a method of managing a wound can comprise applying the
wound management system described herein to a wound. For example, a
method of managing a wound can comprise applying a surgically
acceptable skin adhesive, such as any of the surgically acceptable
skin adhesives described herein, to a wound, and applying a
repositionable surgically acceptable film, such as any of the
surgically acceptable films described herein, over the surgically
acceptable skin adhesive. The method can further comprise
repositioning the repositionable surgically acceptable film after
it is applied.
In many cases, it is advantageous to limit or prevent the
surgically acceptable skin adhesive from entering the wound,
although this is not required unless otherwise specified. This can
be accomplished, for example, by drawing skin or other uninjured
tissue around the wound together before applying the surgically
acceptable skin adhesive, by applying a surgically acceptable skin
adhesive that cures rapidly upon application so that it does not
have time to enter the wound, or by providing a surgically
acceptable skin adhesive with sufficiently high viscosity so as to
reduce or eliminate flow of the skin adhesive into the wound.
The surgically acceptable skin adhesive can be applied over the
wound by any method known in the art. Typically, the surgically
acceptable skin adhesive will be applied to the wound as a curable
liquid or gel. In such cases, the curable liquid or gel can be
applied by pouring or dropping, such as with a medicine dropper,
the curable liquid or gel over the wound. Alternatively, such
curable liquids or gels can be applied with an applicator. Suitable
applicators include one or more of a sponge-tipped applicator, a
high-density foam applicator, a flocked-tipped applicator, and a
silicone-tipped applicator. The applicator can be
blister-sealed.
When the surgically acceptable skin adhesive is applied as a liquid
or gel that is cured over the wound, the repositionable surgically
acceptable film can be applied either before or after the
surgically acceptable skin adhesive is cured. For example, if the
repositionable surgically acceptable film is applied after the
surgically acceptable skin adhesive is cured, it can be adapted
(e.g., by appropriate selection of film material and/or film
adhesive) to provide a relatively weak, repositionable or removable
bond to the cured surgically acceptable skin adhesive such that
later repositioning of the film is possible. Similarly, if the
surgically acceptable film is applied before the surgically
acceptable skin adhesive is cured, the surface of the film (or film
adhesive) contacting the uncured skin adhesive should form a
relatively weak, repositionable bond to the skin adhesive, once it
cures. As yet another example, the repositionable surgically
acceptable film can comprise a silicone sheet, or a sheet with a
silicone surface, that "wets" the surgically acceptable skin
adhesive or the subject in a manner similar to that of a
surfactant, thereby repositionably and reversibly attaching to one
or both of the surgically acceptable skin adhesive and the skin. In
such embodiments, a film adhesive may not be required to provide a
repositionable bond between the repositionable film and the skin
adhesive. Variations of and alternatives to these exemplary
strategies for preventing integration of the surgically acceptable
skin adhesive and the surgically acceptable film will be apparent
to a person of ordinary skill in the art.
The step of applying the surgically acceptable film can comprise
contacting the surgically acceptable skin adhesive with the
surgically acceptable film. Alternatively, another material, such
as a wound-healing layer, an absorbent layer, and the like, can be
placed between the surgically acceptable skin adhesive and the
surgically acceptable film.
The method can further comprise applying an absorbent dressing,
such as those discussed herein or others known in the art, over the
surgically acceptable film.
The method can further comprise applying a pharmaceutically
acceptable active agent to the wound. The active agent can be, for
example, one or more of antibiotics, anti-virals, antimicrobials,
moisturizers, vitamins, skin nutrients, beneficial oils, and scar
reducing agents. The wound management system of the present
invention can be removed in 5-7 days after surgery, or after
complete healing (typically about 14 days), but can vary depending
on the nature of the wound and the patient.
The wound management system disclosed herein can also be provided
in the form of a kit. The kit can contain an uncured surgically
acceptable skin adhesive in the form of a liquid or gel, and one or
more surgically acceptable films. Alternatively, the kit can
include an uncured surgically acceptable skin adhesive, and a
curable liquid or gel that can be cured to form a surgically
acceptable film. The surgically acceptable skin adhesive and film
can be one of those described herein, or any other film or skin
adhesive that is acceptable for use in surgery. The amount of
surgically acceptable skin adhesive and surgically acceptable film
in the kit can vary depending on the size of wound the kit is
configured to treat. For example, a kit for treating small or minor
wounds can be provided with relatively small amounts of the
surgically acceptable skin adhesive and film, whereas kits for
treating major or serious wounds or surgery can be provided with
larger amounts of the surgically acceptable skin adhesive and film.
example, the amount of skin adhesive can be about 0.1 to 10 mL,
including about 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mL,
inclusive of all ranges and subranges therebetween. The amount of
surgically acceptable film can include particular non-limiting
embodiments that are described in the following examples.
EXAMPLE 1
A subject has a laceration approximately 5 inches long on the
abdomen. The skin on the sides of the laceration is pulled
together, and an octylcyanoacrylate skin adhesive is applied over
the wound using a blister sealed silicone tipped applicator. The
adhesive is cured to seal the wound. A surgically acceptable skin
film, in the form of a 4 inch by 6 inch rectangular dressing
containing a topical antimicrobial ointment and low-tack pressure
sensitive adhesive, is placed over the octylcyanoacrylate adhesive.
The dressing is repositioned as necessary to optimally cover the
wound. After the wound is healed, the dressing is removed without
disturbing the scar or causing excessive pain to the subject.
EXAMPLE 2
A subject has an avulsion on the torso with an unevenly shaped skin
flap. The skin flap is pulled over the avulsion, and a mixture of
octylcyanoacrylate and butylcyanoacrylate is applied over the skin
flap to seal the wound. A curable silicone gel is applied over the
cyanoacrylate adhesive and allowed to cure to form a repositionable
film. The adhesive and film are transparent, allowing the user to
monitor the course of wound healing by visual inspection.
EXAMPLE 3
A patient had multiple wounds. One wound was treated by applying a
surgical mesh having a curing accelerator (for accelerating the
curing of cyanoacrylates) over the wound. An octylcyanoacrylate
skin adhesive was applied over the mesh. The resultant glue/mesh
composite formed well-supported wound seal, but was intensely
uncomfortable for the patient. The patient requested that the
composite be removed, however, such removal was not possible
because the composite was strongly adhered to the patient's skin
such that tearing it off would reopen the wound.
EXAMPLE 4
A second wound on the same patient described in Example 3 was
sealed with an octylcyanoacrylate skin adhesive, which was allowed
to cure. A repositionable nonwoven film containing an antimicrobial
and silicon skin adhesive (sold under the name Optifoam.RTM.
Gentile Antimicrobial Post-Op Strip) was affixed over the cured
octylcyanoacrylate adhesive. The patient reported a high level of
comfort with this system, which did not overly restrict patient
movement.
The various embodiments described herein allow a person of ordinary
skill in the art to make, use, and practice the invention. However,
such embodiments are not intended to be limiting, unless otherwise
specified. For example, while various specific surgically
acceptable adhesives and films have been described for illustrative
purposes, such specific elements are not intended to be limiting.
Indeed, a person of ordinary skill in the art will find variations,
substitutions, and changes that are within the spirit and scope of
the invention.
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